Durata™ 7120 (UDI 05414734502085)Recalls & reported problems
St. Jude Medical, Inc. · Defibrillation Lead · Class 3 · Implant
All models of Durata (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Durata defibrillator lead has 346 adverse event reports on file, including 25 deaths and 189 injuries. Many reports describe the lead sensing electrical noise as heartbeats, high resistance in the lead, and breaks in it, and some mention shocks that were not needed. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 345
- Deaths reported
- 25
- Injuries reported
- 187
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 345 adverse event reports that list this exact device (DI 05414734502085), received between Jun 10, 2018 and Sep 10, 2026 — classified as 25 deaths, 187 injuries, 133 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (122 reports).
3 other recalls cover devices cleared under the same FDA submission (P950022); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Over-Sensing122
- Signal Artifact/Noise90
- High impedance86
- Adverse Event Without Identified Device or Use Problem45
- Inappropriate/Inadequate Shock/Stimulation26
- Break20
- Capturing Problem20
- Low impedance19
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- No Known Impact Or Consequence To Patient105
- Death21
- Unspecified Infection15
- Insufficient Information13
- No Consequences Or Impact To Patient13
- Therapeutic Effects, Unexpected11
- Shock from Patient Lead(s)9
Recent adverse event reports
The 25 most recent of 345 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50718194 ↗MalfunctionJun 24, 2026High impedance
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612269 ↗MalfunctionJun 19, 2026No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OCCURRING DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 25568472 ↗MalfunctionMay 19, 2026Signal Artifact/Noise
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. FURTHER INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25224871 ↗DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25081507 ↗InjuryApr 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCK DUE TO RIGHT VENTRICULAR (RV) LEAD NOISE. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050324 ↗InjuryApr 30, 2026Fracture
IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026, DUE TO FRACTURE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044353 ↗InjuryMar 19, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET DUE TO NOISE OVERSENSING EXHIBITED BY THEIR RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT INTO CLINIC AND PROGRAMMING CHANGES WERE MADE. THE RV LEAD WAS THEN EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643328 ↗InjuryMar 19, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT INTERMITTENT OVERSENSING OF RIGHT VENTRICULAR (RV) LEAD NOISE WAS NOTED ON A REMOTE TRANSMISSION. THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY AS A RESULT OF OVERSENSING THE RV LEAD NOISE. THE RV LEAD WAS CAPPED AND REPLACED WITH A COMPETITOR PRODUCT ON (B)(6) 2026. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639352 ↗InjuryMar 17, 2026Capturing Problem
IT WAS REPORTED THAT ELEVATED CAPTURE THRESHOLDS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. OTHER PARAMETERS WERE STABLE. THE RV LEAD WAS CAPPED ON (B)(6) 2026 AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24622232 ↗InjuryMar 9, 2026Failure to Capture
IT WAS REPORTED DURING GENERATOR CHANGE THAT THE RIGHT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE. THE LEAD WAS CAPPED ON (B)(6) 2026 AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547907 ↗MalfunctionMar 3, 2026High impedance
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH DEFIBRILLATION IMPEDANCE. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503111 ↗MalfunctionMar 3, 2026Signal Artifact/Noise
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497577 ↗InjuryFeb 2, 2026High impedance
IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH DEFIBRILLATION IMPEDANCE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. A FRACTURE OF THE LEAD WAS NOT ALLEGED BY THE HEALTHCARE PROVIDER. NO INFORMATION REGARDING INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24241697 ↗MalfunctionJan 19, 2026Break; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING, WHICH RESULTED IN PACING INHIBITION. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109508 ↗MalfunctionJan 15, 2026Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Low impedance
NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAILED TO DELIVER HIGH VOLTAGE THERAPY DUE TO LOW, OUT OF RANGE DEFIBRILLATION IMPEDANCE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24083093 ↗MalfunctionJan 9, 2026High impedance
IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH IMPEDANCE NOTED ON THE RIGHT VENTRICULAR LEAD. FURTHER EXAMINATION WAS RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24031081 ↗InjuryDec 9, 2025Break; Over-Sensing; Break; Over-Sensing
NEW INFORMATION INDICATED THAT AN INSULATION BREACH WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756820 ↗InjuryDec 5, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED OVERSENSING. ON (B)(6) 2025, THE PHYSICIAN CAPPED THE RA AND RV LEAD. THE RV LEAD WAS REPLACED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724763 ↗InjuryAug 8, 2025Break; Failure to Capture; Fracture; Break; Failure to Capture; Fracture
IT WAS REPORTED THE DURING A ROUTINE DEVICE CHANGE, RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE NOT CAPTURING. FRAYING WAS NOTED IN BOTH LEADS ON CHEST X-RAY. BOTH LEADS WERE EXPLANTED AND REPLACED. THE PATIENT IS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749394 ↗MalfunctionJul 2, 2025Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 22387417 ↗MalfunctionJun 11, 2025Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185820 ↗InjuryMay 19, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance
IT WAS REPORTED THAT HIGH PACING IMPEDANCE AND NOISE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. ON (B)(6) 2025, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22048268 ↗MalfunctionApr 18, 2025High impedance; High impedance
IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH HIGH DEFIBRILLATION IMPEDANCE. NO CHANGES WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21866931 ↗MalfunctionMar 26, 2025Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE LEAD WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21698436 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P950022. One submission often covers many models, so check the product and lot details in each record.
- Z-0660-2016 · Nov 3, 2015 · TerminatedOptisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Car
- Z-0457-2012 · Nov 28, 2011 · TerminatedSt. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads co
- Z-0458-2012 · Nov 28, 2011 · TerminatedSt. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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